Pyrofree® Sterile Open Vials manufactured from SCHOTT Type I Fiolax Glass tubing and processed by Disposable Labs.
SCHOTT Fiolax Type I Glass Vials are processed and depyrogenated by Disposable Lab under cGMP conditions to produce Pyrofree® Sterile Open Vials, which are supplied with full Sterility and Endotoxin Certification.
Your choice of Type I Glass Injection Vial is first washed with WFI (Water For Injection) then packed under vacuum into two layers of PEEK polymer, a novel polymer able to withstand the high temperatures of a depyrogenation oven.
The glass vials in the PEEK pouches are then sterilised by dry heat according to a validated process in a depyrogenation oven. The PEEK pouches are then vacuum packed in a third PE/EvOH/PA pouch to offer protection.
Pyrofree is the only packaging process that enables the vials to be depyrogenated in their final packaging which eliminates any risk of endotoxin contamination during the oven exit or further handling.
In addition, as vials are packed under vacuum, the integrity of the vacuum guarantees the sterility of the vials and also provides tamper evidence.
The major benefit of the conventional dry heat sterilisation method used to process these Sterile Open Vials is, unlike sterilisation through EtO, any trial work conducted using these vials is easily replicated on scaled up production equipment.
2ml and 10ml versions are available from stock, with further sizes made to order.
Please Contact Us for further information.